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NCT01204203 · REGISTRY CONDITION SEARCH

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-05-24

The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Response Rate Following Zoledronic Acid (Zometa)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Males and females \> 18 years of age * Life expectancy of at least 2 months * Histologically confirmed unresectable malignant pleural mesothelioma (MPM) * Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening * ECOG Performance Status of 0-2 * Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows: 1. ANC ≥ 1.5 x 109/L 2. Platelet Count ≥ 100 x 109/L 3. Hemoglobin ≥ 9g/dL 4. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) 5. AST ≤ 2.5 x ULN 6. ALT ≤ 2.5 x ULN 7. ALK-P ≤ 3 x ULN 8. Serum creatinine ≤ 1.8mg/dL 9. Calculated Serum Creatinine Clearance 40 - \> 60ml/min * Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial. * Willing and able to provide written informed consent. Exclusion Criteria: * Known central nervous system (CNS) tumor involvement * Evidence of other active malignancy requiring treatment * Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months) * Known infection with HIV or hepatitis * Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible. * Active, serious systemic disease, including active bacterial or fungal infection. * Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw. * Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy. * Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.
healthy Volunteers
false
minimum Age
19 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
    intervention Names
    1. Drug: Zometa
    label
    Zometa
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Zometa
    description
    Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.
    name
    Zometa
    other Names
    1. Zoledronic acid
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
8
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
    measure
    Tumor Response Rate Following Zoledronic Acid (Zometa)
    time Frame
    Baseline up to 28 months or until progressive disease or death
secondary Outcomes
  1. description
    Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.
    measure
    Progression Free Survival (PFS)
    time Frame
    Baseline up to 28 months
  2. description
    Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.
    measure
    Overall Survival (OS)
    time Frame
    Baseline up to 28 months
Full study description
brief Summary
The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.
detailed Description
This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      requested nct id
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      primary nct id
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      source kind
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      source record id
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      payload
      clinical indication matching status
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT01204203
        start
        0
      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      source json pointer
      /studies/21/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice